Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser

Carl Zeiss Meditec

Status: Not yet enrolling

Conditions: Presbyopia

Treatments: Device: MEL90 excimer laser - PRESBYOND

Study type: Observational

Funder types: Industry

Identifiers

NCT06960785

GPAS-REF-024-02

Details and patient eligibility

About

The goal of this clinical trial is to collect information on vision outcomes in people aged 45 to 65 who have difficulty seeing clearly at near distances due to aging (a condition called presbyopia). All participants will receive the same treatment: laser eye surgery with the PRESBYOND method using the MEL 90 excimer laser.

The main questions this study aims to answer are:

• How well do patients see at distance, intermediate, and near after treatment?
• How satisfied are patients with their vision after surgery?

Participants will:

• Attend seven visits over six months (before surgery and after surgery at 1 day, 1 week, 1 month, 3 months, and 6 months)
• Undergo laser eye surgery with PRESBYOND
• Complete vision tests and questionnaires about their experience

There is no comparison group in this study.

Enrollment: 75 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects between 45 and 65 years old
2. Scheduled to undergo bilateral LASIK treatment with PRESBYOND
3. Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye
4. Normal corneal topography in each eye
5. Discontinue use of contact lenses at least 1 month for hard contacts and 1 week for soft lenses prior to the preoperative examination
6. Residual stromal thickness ≥250 microns in each eye
7. Availability, willingness, to comply with examination follow up visits
8. Signed informed consent and data protection documents
9. Patients successfully passed the tolerance test

Exclusion criteria

1. Mixed astigmatism in any eye
2. Irregular corneal astigmatism in any eye
3. Clinically significant ocular surface disease in any eye
4. History of ocular surgery, ocular pathology, or other significant ocular findings that, in the Investigator's opinion, may increase the patient's risk for corneal refractive surgery or affect potential visual outcomes in each eye
5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye
6. Amblyopia, strabismus, nystagmus, forme fruste keratoconus in any eye
7. Clinically significant pupil abnormalities in any eye
8. Use of systemic or ocular medications that may affect visual outcomes
9. Systemic pathology that may affect the results of the study
10. Pregnancy or being treated for conditions associated with hormonal fluctuation
11. Participation in another clinical trial in the last 30 days

Trial design

75 participants in 1 patient group

PRESBYOND

Description:

Participants in this group will receive a personalized laser eye surgery for the correction of presbyopia (Presbyond). The treatment is planned individually for each patient and performed on both eyes. It involves creating a corneal flap with a femtosecond laser, followed by reshaping the cornea with an excimer laser to improve vision at different distances. One eye is mainly corrected for distance and the other for near vision, allowing the brain to combine both images and support everyday visual tasks without glasses.

Treatment:

Device: MEL90 excimer laser - PRESBYOND